Joachim Bier - Consultant Medical Affairs & Clinical Affairs

Heidelberg, Germany

Experience

Jan 2015 - Present

10 years 7 months

Medical director & medical manager.
Launch experience.
Planning clinical development program.
Information officer function.
KOL-management.
Study protocol writing.
Medial monitoring.
Medical scientific liaison-management and training; medical information.
Market access.
Organization of symposia/congresses.
Medical monitoring, global clinical development.
Clinical development, immune defects; HAE.
Interims medical support and regulatory service.
MSL training and interims lead MSL team; experience with nephrology (phosphate binders).
Interims medical manager Cystic fibrosis.
Early business strategy and & development.
Ph I study project COPD.
Sales training pain management.
Interims medical director function.
Interims medical lead medical affairs & market access pain management/ Women´s Health.
Medical support and project management of global clinical trial Ph III.
Medical support biosimilars.
Clinical development manager.
Clinical development.
Sales training pain management.
Medical director, hemato/onco.
Medical affairs support Cystic fibrosis.

Jan 2009 - Dec 2015

5 years

Germany

Part of a small senior management team for the successful clinical development and market growth of the clinical product portfolio.
Reporting to company owner (CEO), communicating with the entire international management team on clinical strategy, operational, financial and commercial issues.
Participated in the development of company strategic and financial planning.
Supervising the clinical development, regulatory and pharmacovigilance teams.
Responsible for the clinical development strategy and their activities worldwide.
Timing and budgeting of the clinical trial program.
KOL management.
Presenting and speaking on behalf of the company in conferences and congresses.
Providing training for internal staff members.
CRO management.
Communicating with regulatory bodies in China, Japan, US and Europe.
Supervising the marketing and international sales managers team.
Instrumental in building the Headquarter “Marketing Team”.
Established financial controls, budgeting and time controls.
Providing training for marketing and product managers.
Writing the annual business plan for the clinical business unit.
Strategic planning and implementation.
Communicating with country manager.
Set up of a clinical business team in China.

Jan 2008 - Dec 2010

3 years

Germany

Reporting to CEO, part of the local senior management team.
Therapeutic areas: Cardio-vascular, pain and tissue management, osteoporosis, immunology, respiratory diseases.
International medical director medical strategy and medical marketing.
Reporting to global head clinical development, 8 direct reports, 20 indirect.
Therapeutic indications: Nephrology, pain management, tissue regeneration and management, osteoporosis.

Jan 2001 - Dec 2008

7 years

Germany

Reporting to medical director.
Responsible for the DACH clinical development program of Tacrolimus in organ transplantation and psoriasis.
Responsible for international paediatric clinical trial programs in kidney and heart transplantation.
International clinical and marketing project management for the.
Clinical trial program management.
Liaising with regulatory, pharmacovigilance, market research, marketing and sales.

Many years quality experience in a variety of challenging Senior Medical roles within Pharmaceutical and Biotech Companies
Long-time experience in planning, coordinating, and managing of clinical development global trial programs

Main skills:

Broad experience in various therapeutic Areas:

Oncology and Haematology, Allergology, Cardiology (e.g. heart failure, myocarditis), Dermatology, Diabetes mellitus, Endocrinology, Immunology, Infectious Diseases, Nephrology, incl. dialysis, Respiratory, Transplantology, Urology, Women’s Health, Wound management